NCT05914961

Immunotherapy-related CRP Kinetics in Early and Metastatic Triple-negative Breast Cancer

ICK-Breast: Immunotherapy-related CRP Kinetics in Early and Metastatic Triple-negative Breast Cancer

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 225 (estimated)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

ICK-breast is a prospective, multicentric, non-interventional investigator-initiated trial (IIT) that aims to investigate the prognostic value of CRP kinetics in early and advanced or metastatic triple negative breast cancer (TNBC) under immune checkpoint inhibitor (ICI) therapy on pathological complete response (pCR) and event-free survival in early TNBC patients, and objective response rate (ORR), progression-free survival (PFS) and overall survival (OS) in advanced or metastatic TNBC.

Detailed description

Immunotherapy, which involves activating the body's immune system for cancer treatment, has already been widely incorporated into the standard care of breast cancer patients with early and metastatic triple-negative breast cancer (TNBC). This study aims to investigate how inflammatory markers such as C-reactive protein (CRP) change during and after immunotherapy. Study findings from other tumor types (kidney, lung, bladder) suggest that immunotherapy is particularly effective when a mild inflammatory response is triggered in the body. The investigators want to examine this using CRP measurement. CRP measurement can easily be integrated into clinical routine as it only requires a blood sample. And since the patients already need a blood draw for chemotherapy, CRP measurement can be performed directly from the blood sample. The goal of this prospective study is to determine whether changes in CRP levels in the blood can predict the disease progression or response to immunotherapy.

Conditions

• TNBC - Triple-Negative Breast Cancer

Timeline

• Start date: 2024-06-01
• Primary completion: 2027-04-01
• Completion: 2035-04-01
• First posted: 2023-06-22
• Last updated: 2026-02-12

Locations

1 site across 1 country: Germany